Treatments for a patient with congestive heart failure

ABSTRACT

The invention is directed to two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, and devices and systems for such procedures. One procedure involves providing a valved passageway through the patient&#39;s left ventricular wall at the apex of the patient&#39;s heart and advancing instruments through the valved passageway to connect the valve leaflets of the patient&#39;s heart valve, e.g. the mitral valve, in a “Bow-Tie” configuration to prevent or minimize regurgitation through the valve. The second procedure involves advancing a pacing lead and a pacing lead implanting device through a trocar in the patient&#39;s chest and implanting the pacing lead on an exposed epicardial region of the patient&#39;s heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall. One or both procedures may be performed on a patient with CHF. 
     Improved devices for these procedures include a minimally invasive grasping device having an inner lumen for advancing connecting members and other instruments through the device to the distal end thereof. Other improved devices include a pacing lead implant instrument which is releasably secured by its distal end to the exposed heart wall to facilitate penetration of the pacing lead electrode into the heart wall. Other improved instruments include a leaflet connector with an artificial cordae tendenae strand secured to an end of the leaflet connector.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of application Ser. No.10/295,390, filed on Nov. 15, 2002 which is related to and claims thepriority of Provisional Application No. 60/340,062, filed Dec. 8, 2001,Provisional Application Ser. No. 60/365,918, filed Mar. 20, 2002, andProvisional Application Ser. No. 60/369,988, filed Apr. 4, 2002. Theentire contents of these applications are incorporated herein byreference.

BACKGROUND OF THE INVENTION

This invention is directed to therapeutic procedures for a patient'sheart and to instruments and systems for such procedures. The inventionis particularly suitable for treating a patient suffering from thesymptoms of congestive heart failure (CHF), and particularly to thoseCHF patients exhibiting mitral valve regurgitation (MVR) and/or thoseexhibiting intraventricular conduction delay with resulting disturbanceof the synchronous right and/or left ventricular contractility.

There are over five million patients in the United States suffering fromCHF and there are more than seven hundred thousand new cases of CHF eachyear. For many of these patients medical therapy is not very successful.Recent trials have shown that a significant number of CHF patient'sbenefit from percutaneous ventricular pacing where pacing leads areintroduced percutaneously and advanced within the patient's vasculatureuntil the leads are disposed within the patient's coronary sinus.However, ventricular pacing has not been found successful for asignificant number of CHF patients for a variety of reasons. Forexample, in a number of procedures the coronary sinus cannot becannulate due to dilated cardiomyopathy (the deformity of the heartwhich accompanies CHF) and, even if the coronary sinus is cannulated,the pacing leads can become displaced rendering them ineffective.

With many CHF patients, their ventricular ejection fraction is reduceddue to mitral valve regurgitation (MR) which may also result fromdilated cardiomyopathy. The MR in turn can exacerbate the cardiomyopathyleading to a worsening of the MR. The MR can also be the result of torncordae tendenae which extend from the valve leaflets to the papillarymuscles, preventing complete closure of the valve.

Surgical procedures for mitral valve repair for MR typically involvesvalve support ring at the base of valve. Recent advances in mitral valverepair include securing together the free edges of the mitral valveleaflets by sutures, staples and the like, commonly called “Bow-Tie” or“edge to edge” techniques. These procedures usually involve open heartsurgery, including cardiopulmonary bypass and a sternotomy, althoughmore recently suggestions have been made of performing these procedureswith minimally invasive and percutaneous techniques which can reduce themorbidity of such procedures. Percutaneous procedures imposedifficulties in instrument design because the instruments for suchprocedures must be long enough to extend from the entry location on thepatient's leg to the interior of the patient's heart chamber, and theymust have small enough profile and have sufficient flexibility foradvancement through the patient's vasculature into the patient's heartchamber. Additionally, the instruments for such percutaneous proceduresmust also be able to accurately locate the operative distal ends of suchinstruments at a desired location within the chambers of the patient'sbeating heart and be strong enough to perform the required functions.

Techniques for Bow-Tie repair of mitral valves have been mentioned inthe patent literature, but specific instruments for such techniques arenot yet commercially available.

SUMMARY OF THE INVENTION

This invention generally relates to minimally invasive therapeuticprocedures, including valve repair and ventricular pacing, for patientswith CHF and to the devices and systems suitable for use in suchprocedures. Specifically, one feature of the invention is directed togaining access to the patient's heart valve, preferably from within theheart chamber. Such acces may be gained through the wall of thepatient's heart, such as at the apex thereof, for repairing damaged orotherwise incompetent heart valves. The invention is also directed tothe attachment of a pacing lead to an exterior region of the patient'sheart wall for ventricular pacing. These procedures provided alone andparticularly when performed together provide significant relief andlonger life to symptomatic CHF patients. Moreover, due to the minimallyinvasive nature of these procedures, many of the CHF patient population,who are otherwise unsuitable for conventional surgical treatments, maybe treated with the present procedures. As used herein the expression“minimally invasive” refers to procedures in which one or more smallopenings are made in a patient's chest wall to insert the instruments tobe used in performing or observing the procedure. Typically, suchprocedures utilize trocars within the small chest wall openings havinginner lumens with transverse dimensions not greater than 20 mm,preferably about 5 to about 15 mm.

The procedure related to valve repair generally includes first gainingaccess to the patient's chest cavity through a small opening made in thepatient's chest, preferably though an intercostal space between two ofthe patient's ribs. Such accessing can be effected thorocoscopicallythrough an intercostal space between the patient's ribs by minimallyinvasive procedures wherein a trocar or other suitable device is placedwithin the small opening made in the patient's chest.

To the extent required, the patient's deflated lung is moved out of theway, and then the pericardium on the patient's heart wall is removed toexpose a region of the epicardium. The patient's heart wall is piercedat the exposed epicardial location to provide a passageway through theheart wall to a heart cavity such as the left ventricle, defined in partby the pierced heart wall. Preferably, the passageway is formed througha region of the heart wall at or near the apex of the patient's heart.Suitable piercing elements include a 14 gauge needle. A guide wire isadvanced through the inner lumen of the needle into the heart chamberand further advanced through the valve to be treated, e.g. the mitralvalve, into an adjacent heart chamber. The penetrating needle may thenbe removed leaving the guide wire in place. A valve for the ventricularwall is advanced over the guide wire and installed in the ventricularwall passageway formed by the needle. The valve is configured to enablepassage of instruments for the procedure through the heart wall into theheart chamber while preventing loss of blood through the passageway. Thevalve may be disposed permanently or temporarily within the heart wallpassageway.

The valve has a cylindrical body with a valve element disposed within aninner lumen of the cylindrical body. At least the distal end andpreferably both ends of the valve are provided with securing elementssuch as hooks or barbs to fix or otherwise secure the valve within theheart wall passageway. An inflatable dog-boned shape balloon may beutilized to seat the securing elements of the valve within thepassageway. Suitable other means for securing valve in the ventricularwall include adhesives, sutures, clip and the like. The valve elementwithin the inner lumen of the valve may take a variety of forms, but aduck-billed valve oriented toward the heart chamber is presentlypreferred.

The instruments for performing the procedure may be passed through thevalve seated in the ventricular passageway. The proximal ends of theseinstruments extend out of the patient to allow the instruments to bemanually or robotically manipulated to accurately position the operativeends of the instruments at the desired location within the heart chamberto perform the procedure and to operate the operative member which maybe provided on the distal ends of these instruments from outside thepatient's body.

For “Bow-Tie” valve repair on a beating heart, the valve leaflets shouldbe stabilized to facilitate grasping the leaflets with a suitablegrasping device at a grasping location and then securing the free edgesof the valve leaflets together by suitable connecting members such asone or more sutures, clips or staples or adhesive to form the “Bow-Tie”connection. A suitable stabilizing instrument, particularly for mitralor atrioventrical valve repair, is an elongated catheter having one ormore expandable members on a distal location thereof, such as aninflatable balloon or expandable arms, which can engage the atrialsurface of the valve leaflets to stabilize and urge the valve leafletstoward the grasping location. The grasping member grasps and holds thevalve leaflets together so that the free edges of the leaflets can besecured together by suitable connecting member or element. The elongatedstabilizing instrument is advanced through the ventricular wall valve,through the heart chamber defined in part by the ventricular wall untilthe distal extremity of the instrument having the expandable member(s)is advanced through the heart valve into the heart chamber beyond theheart valve, which in this case is the left atrium. The expandablemember(s) e.g. an inflatable balloon or one or more arms are expandedand then the stabilizing instrument is pulled proximally so theexpandable member(s) engage the atrial side of the valve leaflets andmove the valve leaflets into the grasping location within theventricular chamber, e.g. left ventricle.

An elongated grasping device with at least a pair of grasping memberssuch as jaws on the distal end thereof for grasping tissue structure isadvanced through the ventricular wall valve until the distal end of thedevice extends into the heart chamber. The grasping members or jaws ofthe grasping device are operated from the proximal end of the graspingdevice which extends out of the patient's chest. The jaws of thegrasping device are opened to receive the stabilized valve leaflets inthe grasping location and then closed to grip the leaflets so that thefree edges of the valve leaflets are placed into an operative positionfor the “Bow-Tie” repair. The free edges of the grasped valve leafletsmay be joined or otherwise secured together by suitable connectingelements. Once the free edges of the valve leaflets are securedtogether, the instruments for the procedure may be withdrawn through theventricular wall valve and then the opening in the patient's chest. Theventricular wall valve will close upon instrument removal to eliminateor at least minimize blood leakage through the valve. The ventricularwall valve may be left in place or the valve may be removed and thepassageway sutured or otherwise suitably closed.

When there is cordae tendenae damage with the heart valve, particularlywhen there is severance of the cordae tendenae from the valve leaflet orthe papillary muscle, repair of the valve leaflet, even by means of the“Bow-Tie” technique, may not prevent reshaping of the ventriculararchitecture which can reduce ventricular output.

In that instance, it has been found that providing an artificial cordaetendenae such as a strand with one end secured to the secured valveleaflets and another end secured to the heart wall, particularly in thesame orientation as the natural cordae tendenae, will support theconnected valve leaflets in more or less a normal manner to minimizeventricular deformation (e.g. dilated cardiomyopathy) which leads todecreased output. One end of the strand is secured to the connectingelement securing the free edges of the valve leaflets or to theconnected free edges themselves and the other end of the strand issecured to a location on the heart wall, preferably on the exterior ofthe heart wall passing through the ventricular wall valve or if thevalve is removed through the ventricular wall passageway. The strandshould be relatively inelastic or non-compliant to ensure an effectiveclosed position of the leaflets. A suitable strand material ispolytetrafluoroethylene (PTFE). In this case it is preferred that thepassageway through the ventricular wall pass through the apex region ofthe heart between the two papillary muscles in the left ventricle, sothat the pull on the valve leaflets by the strand secured to theleaflets is in approximately the same angle or orientation as thenatural pull by the competent cordae tendenae. This provides for abetter seal of the leaflets and thereby minimizes leakage through thevalve. The “Bow-Tie” procedure in conjunction with the use of anartificial cordae tendenae extending between the secured valve leafletsand the heart wall may be used with mini-thoracotomy procedures and openchest procedures, both on and off pump, in addition to the minimallyinvasive procedures described herein.

While the procedure directed to accessing a patient's heart chamber isprimarily described herein for repairing damaged or otherwiseincompetent valves between chambers of the patient's heart, theprocedure and the instruments for such procedures can be employed in avariety of treatments or diagnoses within the patient's heart chambers.Other procedures which may be performed include transmyocardialrevascularization (TMR), aortic stenting for aortic dissections andaneurysm therapy, removal or clots and vegetations of prosthetic valves,excision of heart tumors, stem cell and vascular growth factorimplantation, ventricular septal defect closure and the like. In TMRprocedures a tissue ablation instrument is advanced into the heartchamber to ablate tissue in an ischemic region of the ventricular wall.It is generally thought that the tissue ablation in the ischemic regioncauses or results in angiogenesis and thus revascularization whichreturns blood flow to the ischemic region. For TMR procedures in someregions of the heart chamber, a guiding catheter having a preshapeddistal tip may be needed to orient the ablating tip to the desiredischemic region of the patient's heart wall. A similar procedure may beutilized to ablate regions of the intraventricular wall to terminate orcurtail arrhythmia. Other procedures are contemplated.

The minimally invasive procedure for placement of a pacing lead having apenetrating electrode is performed through a small opening in thepatient's chest formed in the intercostal space between the patient'sribs. The small opening is preferably provided with a suitable trocarsuch as those available commercially. The pericardium is removed fromthe desired region of the patient's heart to expose the underlyingepicardium. The distal end of the pacing lead is introduced into thepatient's chest cavity through the trocar seated in the small opening inthe patient's chest and the penetrating electrode on the distal end ofthe pacing lead is inserted into the ventricular wall through theexposed epicardial surface. The proximal end of the pacing lead isconfigured to be connected to an electrical power source such as thosepower sources used for pacing purposes. Such power sources produce apulsed electrical output of suitable frequency, current and voltagelevels to control the contraction of the ventricular wall to which thepacing lead is attached. The proximal end of the pacing lead may betunneled subcutaneously to the power source which is preferably locatedin the infraclavical pocket. The penetrating electrode preferably hasone or more hooks or other suitable structure for preventing orminimizing the chances for removal of the electrode from the heart wall.The penetrating electrode on the distal end of the pacing lead may takethe form of an arrow, fish-hook or helical coil. Other shapes aresuitable.

The devices suitable for installing the pacing lead in the exterior ofthe heart wall are configured to be advanced through the trocar or smallopening in the patient's chest and to press or otherwise put thepenetrating electrode of the pacing lead within the ventricular wall.The device has a vacuum or other suitable system such as releasablehooks or grasping components on the distal end thereof to secure thedistal end of the device to the exposed surface of the epicardium inorder to facilitate the placement of the penetrating electrode. Thepacing lead and the delivery device are operatively connected with aforce applying member that applies the force to the distal portion ofthe pacing lead required for the electrode to penetrate the ventricularwall. Once the electrode is properly secured within the ventricularwall, the electrical pulses emitted from the pacing electrode overridethe natural pulses to control the contraction of the heart wall.

The blood flow output from the CHF patient's heart due to the pacing andvalve repair in accordance with the present invention is greatlyincreased, and leads to significant improvement in the physical wellbeing, the life extension and the quality of life of the CHF patient.

These and other advantages of the invention will become more apparentfrom the following detailed description and accompanying exemplarydrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a patient's chest, partiallyillustrating the location of the patient's heart within the chestcavity, with part of the heart wall removed to expose the leftventricular chamber and to illustrate torn cordae tendenae connected toone of the valve leaflets.

FIG. 2A is a transverse cross-sectional view taken along the lines 2-2shown in FIG. 1 illustrating the incompetent mitral valve in a closedcondition during systole.

FIG. 2B is a transverse cross-sectional view taken along the lines 2-2shown in FIG. 1 illustrating the incompetent valve in an open conditionduring diastole.

FIGS. 3A and 3B are transverse cross-sectional views similar to thoseshown in FIGS. 2A and 2B but illustrating a competent mitral valve.

FIGS. 4A and 4B are transverse cross-sectional views similar to thoseshown in FIGS. 2A and 2B wherein the valve leaflets are secured togetherin a “Bow-Tie” configuration.

FIG. 5 is a partial elevational view in section of a patient's leftventricle and left atrium illustrating a ventricular wall valve seatedin the apical ventricular wall.

FIG. 6 is an enlarged perspective view of the ventricular wall valveshown in FIG. 5.

FIG. 7 is an enlarged elevational view in section taken along the lines7-7 shown in FIG. 6.

FIG. 8 is a top view of the valve taken along the lines 8-8 shown inFIG. 6.

FIG. 9 is a partial elevational view, in section of the left side of thepatient's heart illustrating the positioning of a guide wire in thepatient's heart interior with the shaped distal tip of a guide wire inthe patient's left atrium.

FIG. 10 is a partial elevational view, in section of the left side ofthe patient's heart illustrating the advancement of a grasping deviceover the guide wire shown in FIG. 9.

FIG. 11 is a partial elevational view, in section of the left side ofthe patient's heart illustrating the positioning of the grasping memberson the distal end of the grasping device shown in FIG. 10 over the guidewire into the patient's left atrium.

FIG. 12 is a partial elevational view, in section of the left side ofthe patient's heart illustrating the advancement of a balloon catheterinto an inner lumen of the grasping device for deployment within thepatient's left atrium.

FIG. 13 is a partial elevational view, in section of the left side of apatient's heart illustrating the inflation of the balloon on the distalend of the balloon catheter within the patient's left atrium.

FIG. 14 is a partial elevational view, in section of the left side of apatient's heart illustrating the positioning of the valve leaflets in agrasping location by the balloon catheter with the open grasping membersof the grasping device being disposed within the left ventricle in aposition to grasp the valve leaflets.

FIG. 15 is a partial elevational view, in section of the left side of apatient's heart illustrating the grasping of the valve leaflets by thegrasping members of the grasping device.

FIG. 16 is a partial elevational view, in section of the left side of apatient's heart illustrating the connecting the free edges of the valveleaflets with a clip in a Bow-Tie arrangement.

FIG. 17 is an enlarged view of the distal end of the grasping device asshown in FIG. 16 with a clip is position partially pressed into aconnecting relationship with the free edges of the valve leaflets.

FIG. 18 is a transverse cross-sectional view taken along the lines 18-18shown in FIG. 17 illustrating the clip partially connected to the valveleaflets.

FIG. 19 is an elevational view of a grasping device embodying featuresof the invention.

FIG. 20 is a transverse cross-sectional view of the grasping deviceshown in FIG. 19 taken along the lines 20-20.

FIG. 21 is an enlarged longitudinal cross-sectional view of the distalend of the grasping device with a valve leaflet connecting clip slidablydisposed within the inner lumen of the grasping device.

FIGS. 22-24 are transverse cross-sectional views taken along the lines22-22, 23-23 and 24-24 respectively of the grasping device shown in FIG.21.

FIG. 25 is a transverse cross-sectional view taken along the lines 25-25of the grasping device shown inn FIG. 21 illustrating the pusher barpushing the leaflet connecting clip along the guide way lumen of thegrasping device.

FIG. 26A is an enlarged elevational view of the clip with an artificialcordae tendenae strand secured to the closed end of the clip. Claim 26Bis an alternative clip construction which has an eyelet for securing theend of the artificial cordae tendenae.

FIG. 27 is a partial elevational view, in section of the left side of apatient's heart illustrating the artificial cordae tendenae extendingfrom the clip to the exterior of the patient's heart.

FIG. 28 is a perspective view of a patient's chest, illustrating thelocation of the patient's heart within the chest cavity, with part ofthe heart wall removed to expose the left ventricular chamber andillustrating placement of the penetrating electrode of a pacing leadwithin the heart wall defining in part the left ventricle.

FIGS. 29-31 illustrate a suitable minimally invasive device forimplanting a pacing lead in a patient's heart wall.

FIG. 32 illustrates typical locations for trocars in a patient's chestfor performing procedures described herein.

FIGS. 33 and 34 illustrate an alternative embodiment of a minimallyinvasive device for implanting a pacing lead in a patient's heart wall.

FIG. 35 is a partial elevational view of an alternative penetratingelectrode construction.

FIG. 36 illustrates another minimally invasive device for implanting apacing lead in a patient's heart wall.

FIGS. 37 and 38 illustrate the grasping of the pacing lead by theminimally invasive device shown in FIG. 35 and the rotation thereof toimplant the electrode in the ventricular wall of a patient.

The drawings are schematic presentations and not necessarily to scale.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

FIG. 1 illustrates a patient's heart 10 with the left side of the heartin partial cross-section schematically showing the patient's left atrium11 and left ventricle 12 with a mitral valve 13 disposed between theleft atrium and the left ventricle having a posterior valve leaflet 14and an anterior leaflet 15. Each of the valve leaflets 14 and 15 havecordae tendenae 16 and 17 respectively which are connected to theleaflets and to papillary muscles 18 and 19 respectively within the leftventricle at the apex 20 of the heart. The posterior leaflet 14 of themitral valve 13 is shown with its cordae tendenae 16 partially torn. Thefree edge 21 of the posterior leaflet 14 is uncontrolled due to the torncordae tendenae 16 which makes the valve incompetent to close completelywhen the heart contracts during systole. The incompletely closed mitralvalve 13 results in regurgitation of blood back through the valve intothe atrium 11 during systole which in turn results in lowered bloodoutput for the left ventricle 12. The anterior valve leaflet 15 is shownwith its cordae tendenae 17 completely attached.

FIGS. 2A and 2B illustrate the closed and open condition respectively ofan incompetent mitral valve 13 such as that shown in FIG. 1. The freeedge 21 of posterior valve leaflet 14 is unable to close completelyagainst the free edge 22 of anterior leaflet 15 due to the torn cordaetendenae as depicted in FIG. 1. A similar leaflet condition may occurdue to dilated ventricular architecture, i.e. dilated cardiomyopathy,which is also characteristic of congestive heart failure.

FIG. 3A illustrates a healthy competent mitral valve 13 with valveleaflets 14 and 15 which are closed completely during systole to preventregurgitation of blood through the valve. FIG. 3B illustrates thecompetent mitral valve shown in FIG. 2A in an opened condition duringdiastole to allow blood to flow from the left atrium to the leftventricle.

FIGS. 4A and 4B illustrate the closed and opened conditions of a mitralvalve 13 in which the free edge 21 of posterior valve leaflet 14 and thefree edge 22 of the anterior leaflet valve 15 are secured together in a“Bow-Tie” connection by a suitable clip, such as is shown in FIG. 26.During systole, when the heart contracts, the clip holds the free edges21 and 22 of the valve leaflets together to minimize blood regurgitationthrough the valve. However, during diastole, when the heart musclerelaxes and the blood pressure within the left ventricle 12 is reduced,the mitral valve 13 opens up much like a competent valve but with twoopenings 23 and 24 between the valve leaflets 14 and 15. Theinterference with blood flow through the two openings 23 and 24 of arepaired mitral valve with a Bow-Tie connection between the leaflets isminimal during diastole compared to the flow with a single opening for acompetent mitral valve.

FIG. 5 illustrates a left side of a patient's heart such as is shown inFIG. 1 with an incompetent mitral valve 13 due to torn cordae tendenae14. A valve 30 embodying features of the invention is deployed within apassageway 31 through the free ventricular heart wall 32. As is shown inmore detail in FIGS. 6-8, the valve 30 has a cylindrical structure 33which is secured within the passageway 31 by elements 34 which may bebarbs or hooks. Other means such as suitable adhesives may be utilizedto secure the valve 30 within the passageway 31. The valve component 35of valve 30 is a duck billed valve component formed of suitablepolymeric material which allow the passage of instruments for deploymentor treatment but prevent or at least minimize loss of blood through theheart wall, particularly during systole. The duck-billed valve component35 extends toward the distal end of the valve 30 to prevent blood flowfrom the heart chamber. The cylindrical structure 33 may be in anopen-walled form similar to a stent and is preferably expandable tofacilitate its deployment within the passageway 31. However, thecylindrical structure 33 may have any suitable structure or be formed ofany suitable material which supports the valve component 35. Thesecuring elements 34 may be forced into the surrounding tissue of theheart wall by means of a dumbbell shaped inflatable balloon (not shown).

FIGS. 9-26 depict a grasping device 40 which embodies features of theinvention and the use of the device to secure the valve leaflets in aBow-Tie connection. The grasping device 40 has an elongated shaft 41, aplurality of grasping members or jaws 42 on the distal portion of theshaft and finger operated handles 43 and 44 which operate the jaws 42through pull wires 45 and 46. The grasping members or jaws 42 arepivotally mounted at the pivot point 47 on the distal end of shaft 41.While only two jaws 42 are shown, three or more jaws may be employed.The elongated shaft 41 of grasping device 40 has an inner lumen 48extending therein to allow for the passage of instruments that aid oreffect the deployment of a connecting member 49 to the free edges of thevalve leaflets to perform a Bow-Tie connection thereof as will bedescribed in more detail hereinafter. FIG. 21 is an enlarged elevationalview in section of the distal portion of the grasping device 40 toillustrate the connecting member 49, which is a leaflet clip, and thepusher bar 50 which pushes the clip through the inner lumen 48 of thegrasping device. As shown in more detail in FIGS. 22-24, tapered grooves51 and 52 are provided in the jaws 42 so that, as the clip 49 is pushedtoward the distal ends of the jaws 42, the open distal ends of the clipslide along the tapering grooves and are closed against free edges 21and 22 of the leaflets 14 and 15 grasped by the jaws. The deployedleaflet clip 49 partially closed against the free leaflet edges 21 and22 in a Bow-Tie connection is shown in FIGS. 17 and 18. The inner lumen48 continues through the jaws 42 to a port 51 to allow passage of otherinstruments such as the distal portion of the balloon catheter 53 whichstabilizes and positions the valve leaflets 14 and 15 in the graspinglocation as shown in FIG. 14.

The use of the grasping device 40 to make a Bow-Tie connection of thefree edges 21 and 22 of the mitral valve 13 is illustrated in FIGS.9-18. After the one-way valve 30 is properly secured within thepassageway 31 through the ventricular wall 32, a guide wire 54 isadvanced through the valve 30 into the left ventricle 12 and furtheradvanced through the mitral valve 13 into the left atrium 11 as shown inFIG. 10. A grasping device 40 is mounted on the proximal end of theguide wire 54 which extends out of the patient and is slidably advancedover the guide wire through the valve 30, and into the left atriumthrough the mitral valve 13. The guide wire 54 at that point is slidablydisposed within the inner lumen 48 of the grasping device 40. A ballooncatheter 53 may then be advanced over the guide wire 54 through theinner lumen 48 of the grasping device 40 until the inflatable balloon 55on the distal portion of catheter 53 is disposed in the left atrium 11.The balloon 55 is inflated by injecting inflation fluid through an innerlumen (not shown) in the shaft of the balloon catheter 53 by means ofthe syringe 56 as shown in FIG. 13. If the shaft of the balloon catheter53 is stiff enough, the guide wire 54 may be withdrawn prior toinsertion of the balloon catheter 53 and the advancement thereof throughthe inner lumen 48 of grasping device 40 by itself.

After the balloon 55 is inflated within the left atrium 11, the ballooncatheter 53 is pulled proximally to press the inflated balloon 55against the atrial side of the mitral valve leaflets 14 and 15 to urgethe leaflets into grasping location as shown in FIG. 14. The jaws 42 ofthe grasping device 40 may then be closed on the valve leaflets 14 and15 as shown in FIG. 15. As previously described, the leaflet clip 49 maythen be advanced through the inner lumen 48 by pusher bar 50 to closethe open ends of clip 49 against and through the grasped free edges 21and 22 of valve leaflets 14 and 15 respectively, as shown in FIGS. 17and 18. After the clip 49 has been deployed to form the Bow-Tieconnection, the grasping device 40 and any other devices that may bepresent are withdrawn from the patient's heart through the ventricularwall valve 30. The duck-billed valve component 35 closes down afterremoval of the various instruments and prevents loss of blood from theleft ventricle. If desired, the valve 30 may be left in place or it maybe removed and the proximal opening of the ventricular passagewaysutured or otherwise closed or sealed.

In FIG. 26A a clip 49 is shown with a strand 57 secured to the closedproximal end. An alternate embodiment is depicted in FIG. 26B in whichthe closed proximal end of the clip 49 is provided with an eyelet 58.One end of the strand 57 is tied to the eyelet. A variety of clipstructures may be employed to connect the free edge of the valveleaflets.

An embodiment is shown in FIG. 27 wherein an elongated strand 57 formedof relatively non-compliant material, such as PTFE, Nylon, polyethyleneterephthalate, has its distal end secured to the closed proximal end ofleaflet clip 49. The strand 57, if formed of PTFE, should have atransverse dimension of about 1 to about 3 mm. After deployment of theclip 49 to connect the free edges 21 and 22 of the leaflets 14 and 15 ina Bow-Tie connection, the proximal end of the strand 57 is pulled tautto position the leaflets 14 and 15 in a position to ensure properclosure during systole and then the proximal end of the strand 57 issecured to the free ventricular wall 32, preferably to the exteriorthereof, such as shown suturing with a pledget 59 while maintaining thestrand in a taut condition. This embodiment is particularly suitable inthose instances wherein cordae tendenae connected to the valve leafletare torn. The strand 57 acts as an artificial cordae tendenae to theleaflet. However, care must be exercised when securing the proximal endof the strand 57 is secured to the heart wall 32 so that the valveleaflets are in a natural position in order to prevent or reduceregurgitation through the mitral valve 13.

The hearts of many CHF patients exhibit intraventricular conductiondelay with resulting disturbance of the synchronous right and/or leftventricular contractility. As previously mentioned, a large populationof the CHF patients are not suitable candidates for or fail percutaneousdelivery of pacing leads to provide relief from CHF. In these instances,it has been found that a pacing lead secured to the exterior walldefining in part the heart chamber exhibiting the conductance delay canbetter control the contraction of the heart and thereby improve thechamber's ejection.

As shown in FIG. 28, the pacing lead 60 can be deployed within thepatient's chest cavity by minimally invasive techniques through a trocar61 located in the intercostal space between the patient's ribs. Theplacement of the pacing lead 60 can be observed by an endoscopic video62 extending through a second trocar (not shown) in a second intercostalspace. Instruments to facilitate the implantation of the helicallyshaped penetrating electrode 63 of the pacing lead 60 can be passedthrough the trocar 61 and the electrode secured within the heart wall 32by minimally invasive techniques. The pacing lead 60 has its proximalend configured to be electrically connected to a pacing power source 64which is preferably disposed at a subcutaneous location. The pulsedoutput of the power source 64 may be controlled in a conventional mannerto provide the desired contractions to the heart wall to which thepacing lead is secured.

FIGS. 29 to 31 illustrate a minimally invasive embodiment havingfeatures of the invention directed to implanting a pacing lead in apatient's heart wall. The delivery and implanting device 70 of thisembodiment includes a tubular delivery member 71 having a proximal end72 with a port 73, an enlarged distal end 74 with a port 75 and innerlumen 76 extending within the tubular member from the proximal port 73to the distal port 75. The distal end 74 of the tubular member 71 isenlarged to receive a longitudinally expansive member such as inflatableballoon 77. The balloon 77 is provided with an elongated shaft 78 havingan inner inflation lumen (not shown) which allows inflation fluid to beintroduced into the interior of the balloon to inflate the balloon. Thedistal end 74 of tubular member 71 is provided with a securing pod orring 79 to releasably secure the distal end to the exposed surface ofthe free ventricular wall 32. The interior chamber 80 of the pod 79 isconnected in fluid communication with the vacuum tube 81 which is inturn configured to be connected in fluid communication with a vacuumsource (not shown). The pacing lead 82 has a collar 83 secured about adistal portion thereof which is configured to be engage by the balloon77 when the latter is inflated. The enlarged end 74 of the tubulardelivery member 71 prevents complete radial expansion of the balloon 77upon inflation and as a result the balloon expands longitudinally. Thelongitudinal expansion of balloon 77 against the collar 83 connected tothe pacing lead 82 drives the penetrating electrode 84 on the pacinglead against the exposed ventricular wall 32 so that the penetratingelectrode 84 penetrates into and is secured within the ventricular wall32 by the barbs 85. The enlarged distal end 74 should be about 5 toabout 15 mm in diameter and about 5 to about 40 mm in length. Othersizes may be suitable. The tubular member 71 may have a flexible section86 to facilitate articulation of the distal extremity of the tubularmember 71 to aid in the placement of the pod 79 to the exterior of theheart wall 32 and provide a sound seal for the application of a vacuum.The vacuum pod 79 is configured to pass through a trocar provided in anintercostal space between the patient's ribs.

The pacing lead 82 shown in FIGS. 29-32 is installed by first making asmall opening in the patient's chest and deploying a first trocar 87such as shown in FIG. 32 having an inner lumen within the small opening.Commercially available trocars include trocars from U.S Surgical andothers. A second similar trocar 88 to place a variety of instrumentswithin the patient's chest cavity for the procedure and a third trocar89 is installed in a similar manner for a thorocoscope which allows theoperating surgeon to view the region in which the pacing lead is to beinstalled. Other trocars may also be installed for other purposes. Asuitable arrangement of trocars 87, 88, 89 for such procedures is shownin FIG. 32.

To install the pacing lead the lower left lobe of the patient's lung,which is deflated, is moved out of the way to expose the patient'sheart. Part of the pericardium on the free wall 32 defining in part thepatient's left ventricle is removed to expose a desired region of theepicardial site in which the pacing lead 81 is to be secured. The pacinglead delivery tube 71 is introduced into the patient's chest cavitythrough the first trocar and advanced within the chest cavity toward theexposed epicardial surface. The distal end facing of the vacuum pod 79on the expanded distal end 74 of the delivery tube 71 is pressed againstthe exposed epicardial surface of the ventricular wall 32 and a vacuumis developed within the inner chamber 80 of the pod 79 to hold thedistal end of the tubular member 71 against the epicardial surface asshown in FIG. 30. Inflation fluid is introduced into the interior of theballoon 77 through the inflation lumen in tube 78 as shown by thearrows. The expanded distal end 74 of the delivery tube 71 limits theradial expansion of the balloon 77, so that the balloon expandslongitudinally in the distal direction as shown in FIG. 31. Thelongitudinal expansion causes the distal end of the balloon to expandagainst the collar 83 secured to the distal portion of the pacing lead81.

Balloon pressure on the collar 83 drives the pacing lead 82 toward theepicardial location and this results in the penetration of electrode 84on the distal end of the pacing lead into the ventricular wall 32. Thebarbs 85 on the penetrating electrode 84 secure the electrode within theheart wall and resist withdrawal of the electrode from the heart wall32. Electrical pulses from a suitable electrical power source areapplied to the proximal end of the pacer lead. The electrical pulses aretransmitted through the pacing lead conductor to the penetratingelectrode 83 secured within the heart wall 32. The pulses are emittedfrom the secured electrode 84 into the tissue of the heart wall 32 topace the patient's left ventricle. The pacing is controlled in order toincrease the volume of blood pumped out of the heart chamber.

An alternative device 90 is shown in FIGS. 33 and 34 which has anelongated tubular shaft 91 with a proximal end 92, a distal end 93, anda semispherical shaped housing 94 on the distal end with a securing pod95 on the distal end 93. The securing pod 95 has an annular vacuumchamber 96 around the lower edge of the semi-spherical housing 94 whichis in fluid communication with the inner lumen 97 of tubular member 98.The proximal end (not shown) of the tubular member 98 is configured tobe connected in fluid communication with a vacuum source (not shown). Aninner lumen 99 extends through the tubular shaft 91 and slidablyreceives the catheter 100 having an inflatable balloon 101 on the distalend thereof. A pacing lead 102 extends along, but exterior to, thetubular shaft 91 and has a distal end with a balloon support platform103 and a tissue penetrating electrode 104 extending away from theplatform.

A distal portion 105 of the tubular shaft 91 is provided with somedegree of flexibility in order to ensure that the spherical housing 94is in a proper orientation to be pressed against and releasably securedto the exposed epicardial surface. With the securing pod 95 securedagainst the epicardial surface of wall 32, the balloon 101 is inflatedto drive the supporting platform 103 and the connected penetratingelectrode 104 toward the epicardial surface. The electrode 104 is driveninto the wall 32 of the patient's left ventricle and the barbs 106thereon secure the electrode within the wall tissue to resist withdrawalof the electrode from its deployed position. Electrical pulses from asuitable power source may then be applied to the tissue within the heartwall to pace the contraction thereof as discussed above to increase theoutput of blood from the heart chamber.

The balloon 101 is releasably secured to the support platform 103 sothat when the electrode 104 is driven into the heart wall 32, theballoon 101 can be deflated and the vacuum within the vacuum chamber ofthe semi-spherical housing may be released and the assembly withdrawnfrom the patient through the trocar through which it was delivered. Theproximal end of the pacing lead may then be directed to the power sourceand connected thereto. The shaft 91 is preferably shapeable in order tobe able to place the pacing lead at the desired location on the exposedepicardial surface. The shaft 91 may be formed of stainless steel, orother metallic or other materials which allow the shaft to be manuallyshaped by the physician prior to insertion into the patient's chestcavity.

The tissue penetrating electrodes 83 and 104 described in the aforesaidembodiments generally have an arrow shape with a pointed distal tip tofacilitate tissue penetration and two outwardly flaring barbs 85 and 106which resist electrode withdrawal once the electrode is in place.Alternate electrode construction includes a fish-hook shaped electrodesuch as shown in FIG. 34 with a pointed distal tip and a singleoutwardly flaring barb. Similar electrode constructions are suitableincluding those having three or more outwardly flaring barbs.

Another alternative embodiment is shown in FIGS. 35-37, which is adevice 120 having an elongated tube 121 with a pair of grasping tongs122 on the distal end 123 of the tube with a mechanism (not shown)configured to secure the tongs 121 to a pacing lead housing 124. Thedevice 120 of this embodiment has a housing 125 on the proximal end 126with a rotating lead holder 127 which when rotated rotates the pair ofgrasping tongs 122 as shown in FIGS. 37 and 38. A release button 128 isprovided on the housing 125 to disengage the grasping tongs 122 from thepacing lead housing 124. The rotation of the tongs 122 causes therotation of the pacing lead housing 124 and the helical electrode 126 toscrew into the heart wall 32. A similar device will soon be offered byMedtronic as an epicardial lead implant tool (Model No. 10626) which isdesigned to be used with a Model 5071 pacing lead.

Usually, an additional (e.g., conventional) pacing lead is installed inthe patient's right ventricle for complete resynchronization of theheart chambers. The additional lead is preferably connected to the samepower source as the first described pacing lead which may be located inthe infraclavicular pocket in a conventional manner.

EXAMPLE

Twenty patients were selected (12 men, 8 women) for thorocoscopicallydirect left ventricular lead placement. The patients had New York HeartAssociation Class III or IV congestive heart failure with a meanejection fraction of 20%±8%. All of the patients had previouslyundergone transvenous right-ventricular lead placement and subcutaneousimplantation of a dual or triple chamber pacemaker but had failedtransvenous left-ventricular lead placement due to suboptimal coronaryvein anatomy. Surgical entry into the left chest was carried out througha 2 cm incision in the mid acillary line at the sixth intercostal space,following collapse of the left lung. A 15 mm thoracoport (trocar 87 inFIG. 32) from U.S. Surgical was inserted with the tip of the trocarpointing to the left minimize contact with the heart. A 5 mm rigid port(trocar 88 in FIG. 32) was inserted inferolateral to the left nipple ofthe patient in the sixth intercostal space to allow insertion of agrasper such as the U.S. Surgical Endograsper. Another 5 mm rigid port(trocar 89 in FIG. 32) was inserted in the fourth intercostal space atthe anterior axillary line for a scope and camera. A portion of thepericardium was removed to provide an exposed epicardial region by agrasper from within trocar 88 for implantation of the helical electrodeof the pacing lead. Screw in epicardiac leads (Medtronic 5071 andGuidant 4047) were inserted through the 15 mm trocar or rigid port undervideo control by a scope within the trocar 89. The leads were insertedinto the epicardium by applying gentle pressure and three clock-wisefull rotations of the pacing lead holder (shown schematically in FIGS.34-36). If pacing voltage thresholds were unacceptably high the pacinglead would be twisted one-quarter turn and then retested. Acceptablepacing lead placement is defined as 100% pacing at 2.5 volts or less.The video assisted left-ventricular lead placement was successful innineteen of the twenty patients. The one failure required an openthorocotomy.

While particular forms of the invention have been illustrated anddescribed, it will be apparent that various modifications can be madewithout departing from the spirit and scope of the invention. Forexample, the vacuum actuated securing pod to secure the distal end of adelivery tube may be replace in whole or part by one or more hooks ortissue gasping components disposed about the distal end of the deliverydevice to releasably secure the distal end to the epicardial surfaceduring electrode placement. To the extent not otherwise described, thevarious components of the devices described herein may be formed ofconventional materials and have conventional structures. Accordingly, itis not intended that the invention be limited to the specificembodiments illustrated. It is therefore intended that this invention tobe defined by the scope of the appended claims as broadly as the priorart will permit. Moreover, those skilled in the art will recognize thatfeatures shown in one embodiment may be utilized in other embodiments.Terms such a “element”, “member”, “device”, “section”, “portion”,“component”, “steps” and words of similar import when used herein shallnot be construed as invoking the provisions of 35 U.S.C. §112(6) unlessthe following claims expressly use the terms “means” or “step” followedby a particular function without specific structure or action. Allpatents and patent applications referred to above are herebyincorporated by reference in their entirety.

1-14. (canceled)
 15. A minimally invasive system for treating apatient's heart having heart valve regurgitation, comprising: a. a valveconfigured to be secured within a passageway formed through thepatient's heart wall to provide instrument passageway into a chamber ofthe patient's heart defined in part by the heart wall through which thepassageway is formed; b. a tissue grasping device configured to extendthrough the valve secured within the passageway into the chamber of thepatient's heart and having at least two grasping members configured tograsp valve leaflets; and c. a tissue connecting member to connect freeedges of valve leaflets. 16-54. (canceled)
 55. A minimally invasivesystem for treating a patient's mitral valve, comprising: a. a valvewhich is configured to be secured within a passageway formed through awall of the patient s heart defining in part a heart chamber and whichallows passage of an instrument through the valve element into a chamberof the patient's heart defined in part by the heart wall withoutsignificant blood loss; and b. a tissue grasping device which isconfigured to extend through the valve secured within the passageway inthe patient's heart wall configured to grasp a free edge of at least onevalve leaflet; and c. an artificial chordae tendineae which has one endwhich is connectable to the free edge of at least one valve leaflet andone end which is secured to the heart wall through which the valveextends.
 56. The system of claim 55 wherein the grasping device has twojaws which are configured to grasp the free edge of at least one valveleaflet to facilitate securing the end of the artificial chordaetendineae to the free edge of the valve leaflet.
 57. The system of claim55 wherein the end of the artificial chordae tendineae has a connectingmember to facilitate securing the end to the edge of the valve leaflet.58. The system of claim 55 including a stabilizing member for engagingat least one valve leaflet and holding the valve leaflet in a graspinglocation.
 59. The system of claim 58 wherein the stabilizing member is aballoon catheter.
 60. The system of claim 59 wherein the ballooncatheter has an inflatable balloon on a distal portion thereof whichengages at least one the valve leaflet.
 61. The system of claim 60wherein the balloon is formed of compliant or semi-compliant polymericmaterials.
 62. The system of claim 55 wherein the jaws of the graspingdevice are configured to grasp the free edges of a pair of valveleaflets.
 63. The system of claim 62 including a tissue connectingmember connected to one end of the artificial chordae tendineae tosecure the end of the artificial chordae tendineae to the free edges ofthe pair of valve leaflets.
 64. The system of claim 55 wherein theartificial chordae tendineae is formed of a non-compliant polymericmaterial.
 65. The system of claim 55 wherein the artificial chordaetendineae is formed of polytetrafluoroethylene and has transversedimensions of about 1 to about 3 mm.
 66. The system of claim 57 whereinthe grasping device comprises: a. a pair of operative handles, with eachhandle being operatively connected to one of the jaws; and b. anelongated shaft having an inner lumen configured to slidably receive theconnecting member.
 67. The grasping device of claim 66 wherein at leastone of the jaws has a tapered groove to at least partially close theconnecting member when the connecting member is advanced distallythrough the inner lumen into the opposing jaws.
 68. The system of claim57 wherein the connecting member has an open distal end and a closedproximal end.
 69. The system of claim 68 wherein an artificial chordaetendineae strand is secured to the closed proximal end of the connectingmember.
 70. The system of claim 64 wherein the artificial chordaetendineae strand is configured to extend between one or more valveleaflets and the heart wall so as to position the valve leaflet having atorn or damaged chordae tendineae into an operating position.
 71. Thesystem of claim 70 wherein the artificial chordae tendineae strand isformed of non-compliant polymeric material.
 72. The system of claim 55wherein the valve leaflet has a torn or damaged chordae tendenae.
 73. Amethod for treating a patient's mitral valve having a valve leaflet,comprising: a. advancing an artificial chordae tendineae having firstand second ends into a chamber defined in part by a ventricular wall ofthe patient's heart; b. securing the first end of the artificial chordaetendineae to a free edge of the valve leaflet from within the patient'sheart; and c. securing the second end of the artificial chordae tendenaeto the ventricular wall which defines in part a heart chamber.
 74. Themethod of claim 73 wherein the free edge of the valve leaflet is guidedto a grasping location.
 75. The method of claim 74 wherein a graspingdevice is advanced through the passageway in the ventricular wall intothe left ventricle and grasps the free edge of the valve leaflet in thegrasping location.
 76. The method of claim 75 wherein the end of theartificial chordae tendenae is secured to the free edge of the valveleaflet when the free edge thereof is grasped by the grasping devices.77. The method of claim 76 including withdrawing the grasping devicefrom the patient's heart and securing one end of the artificial chordaetendineae to the ventricular wall.
 78. The method of claim 73 whereinthe second end of the artificial chordae tendineae extends through apassageway in the patient's ventricular wall and is secured to anexterior surface thereof.
 79. The method of claim 73 including seating avalve into the passageway in the ventricular wall.
 80. The method ofclaim 74 wherein the valve leaflet is guided to the grasping location bya stabilizer member.
 81. The method of claim 80 wherein the stabilizermember is advanced through a passageway through the ventricular wall andwhich extends through the valve leaflets to the up-stream side of thevalve leaflets.
 82. The method of claim 73 wherein the first end of theartificial chordae tendineae is secured to the free edge of the valveleaflet with a connecting member.
 83. The method of claim 73 wherein thefirst end of the artificial chordae tendineae is also secured to a freeedge of an adjacent valve leaflet.
 84. The method of claim 83 whereinthe free edge of the valve leaflet and the free edge of the adjacentvalve leaflet are secured together in a bow-tie configuration.
 85. Themethod of claim 73 wherein the valve leaflet has a torn or damagedchordae tendineae.
 86. A method for treating a patient's mitral valvehaving a valve leaflet with a torn or damaged chordae tendineae,comprising: a. advancing an artificial chordae tendineae having firstand second ends into a chamber defined in part by a ventricular wall ofthe patient's heart; b. securing the first end of the artificial chordaetendineae to a free edge of the valve leaflet from within the patient'sheart; and c. securing the second end of the artificial chordae tendenaewithin the heart chamber oriented with respect to the papillary muscle.87. The method of claim 86 wherein the free edge of the valve leaflet isguided to a grasping location.
 88. The method of claim 87 wherein agrasping device is advanced through the passageway in the ventricularwall into the left ventricle and grasps the free edge of the valveleaflet in the grasping location.
 89. The method of claim 88 wherein thefirst end of the artificial chordae tendenae is secured to the free edgeof the valve leaflet when the free edge thereof is grasped by thegrasping devices.
 90. The method of claim 89 including withdrawing thegrasping device from the patient's heart and securing one end of theartificial chordae tendineae to the ventricular wall.
 91. The method ofclaim 89 wherein the second end of the artificial chordae tendineaeextends through a passageway in the patients ventricular wall and issecured to an exterior surface thereof.
 92. The method of claim 91including seating a valve into the passageway in the ventricular wall.93. The method of claim 87 wherein the valve leaflet is guided to thegrasping location by a stabilizer member.
 94. The method of claim 93wherein the stabilizer member is advanced through the valve leaflets toa location on the up-stream side of the valve leaflets.
 95. The methodof claim 87 wherein the first end of the artificial chordae tendineae issecured to the free edge of the valve leaflet with a connecting member.96. The method of claim 87 wherein the first end of the artificialchordae tendineae is also secured to a free edge of an adjacent valveleaflet.
 97. The method of claim 96 wherein the free edge of the valveleaflet and the free edge of the adjacent valve leaflet are securedtogether in a bow-tie configuration.
 98. The method of claim 87 whereinthe valve leaflet has a torn or damaged chordae tendineae.